NCT03926429

Brief Summary

The aim of this study is to assess the incidence and the clinical and therapeutic characteristics of reactive arthritis and to compare them with those of a historical cohort. We hypothesised that improved hygiene together with prevention and treatment of sexually transmitted infections may have decreased the incidence of reactive arthritis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

1.9 years

First QC Date

April 19, 2019

Last Update Submit

April 23, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • To determine the incidence of reactive arthritis in patients hospitalised in the rheumatology department

    Incidence of reactive arthritis in patients hospitalised in the rheumatology department

    December 2014

Study Arms (1)

Patient with reactive arthritis

Other: Standardised data collection

Interventions

The following variables will be retrospectively assessed by medical record review using a standardised data collection form:demographics; gender, age; family or personal history of spondyloarthritis, psoriasis, uveitis, inflammatory bowel disease; clinical presentation; mono, oligo or polyarthritis, dactylitis, inflammatory joint pain, enthesopathy, axial symptoms, fever, extra-articular manifestations (conjunctivitis, anterior uveitis, circinate balanitis, skin rash); time interval between infection and musculoskeletal manifestations; causal microorganism if known, or triggering event; HLA-B27; radiographic sacroiliitis; treatments and outcomes (complete recovery at one year follow-up, relapse within 6 months after onset, or spondyloarthritis according to the ASAS criteria).

Patient with reactive arthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with active reactive arthritis

You may qualify if:

  • reactive arthritis diagnosed in one of the two rheumatology departments from Centre Hospitalier Lyon Sud or Besançon

You may not qualify if:

  • presence of other known causes of arthritis, such as other defined spondyloarthritides, septic arthritis, Lyme disease, microcrystalline arthritis or rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Besançon

Besançon, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Fabienne COURY-LUCAS, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2019

First Posted

April 24, 2019

Study Start

February 1, 2013

Primary Completion

December 31, 2014

Study Completion

December 31, 2014

Last Updated

April 24, 2019

Record last verified: 2019-04

Locations